BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLXECP KIT

    MDR report key: 1477054 · Received September 16, 2009

    Report

    Report Number
    2523595-2009-00003
    Event Type
    Injury
    Date Received
    September 16, 2009
    Date of Event
    August 20, 2009
    Report Date
    September 15, 2009
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE OPERATOR, AND COULD NOT BE EVALUATED FURTHER BY THE MFR. THIS WAS A USER ERROR IN WHICH THE FLUID LINES WERE INSERTED INTO THE WRONG BAGS. THE GREEN STRIPPED ANTICOAGULANT LINE WAS INSERTED INTO THE SALINE BAG AND THE CLEAR LINE INTO THE BAG WITH 12500 UNITS OF HEPARIN, SO THE PT WAS NOT RECEIVING ANY ANTICOAGULANT.

    Description of Event or Problem · 1

    THE PT UNDERWENT AN ECP TREATMENT WITH AN 80 ML BOWL, 232 ML OF ANTICOAGULANT AND 69 ML OF FLUID BALANCE. THE AMOUNT OF WHOLE BLOOD PROCESSED WAS 896/1500 ML. ORIGINALLY, THE ANTICOAGULANT RATIO WAS 10:1, BUT WAS CHANGED TO 8:1, AS CLOTS WERE OBSERVED IN THE BAG. DURING THE ECP PROCEDURE, THE SYSTEM PRESSURE ALARM SOUNDED AND THE BOWL APPEARED TO BE CLOTTED. THE OPERATOR CHECKED THE KIT AND NOTED THE WRONG LINES WERE IN THE ANTICOAGULANT BAG. THE ECP OPERATOR THEN NOTIFIED THE CLINIC PHYSICIAN, ABORTED THE ECP TREATMENT AND ADMINISTERED 500 ML OF GELOFUSINE (4% SUCCINYLATED GELATIN SOLUTION FOR INJECTION; B BRAUN). THE TOTAL ECP TREATMENT TIME WAS 78 MINS. ADDITIONAL SAMPLES WERE TAKEN FOR LAB EVAL AND CROSS-MATCHING FOR BLOOD TRANSFUSION, AND THE PT WAS HOSPITALIZED OVERNIGHT IN THE HOSPITAL WARD. THE PT WAS SCHEDULED TO HAVE A TRANSFUSION ON THE NEXT MORNING AND A REPEAT ECP PROCEDURE WAS SCHEDULED FOR THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLXECP KIT CELLEX PHOTOPHERESIS KIT LNR THERAKOS CLXECP X103

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention